Calcort 6mg Tablets - (eMC) print friendly 02/07/15 22:05 Calcort 6mg Tablets Summary of Product Characteristics Updated 26-May-2015 | SANOFI 1. Name of the medicinal product Calcort 6mg Tablets 2. Qualitative and quantitative composition Active ingredient: deflazacort 6mg 3. Pharmaceutical form Round, white, uncoated tablets, marked with a cross on one face and a 6 on the other face. 4. Clinical particulars 4.1 Therapeutic indications A wide range of conditions may sometimes need treatment with glucocorticoids. The indications include: • Anaphylaxis, asthma, severe hypersensitivity reactions • Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica • Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyarteritis nodosa, sarcoidosis • Pemphigus, bullous pemphigoid, pyoderma gangrenosum • Minimal change nephrotic syndrome, acute interstitial nephritis • Rheumatic carditis • Ulcerative colitis, Crohn's disease • Uveitis, optic neuritis • Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura • Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma • Immune suppression in transplantation 4.2 Posology and method of administration Deflazacort is a glucocorticoid derived from prednisolone and 6mg of deflazacort has approximately the same anti- inflammatory potency as 5mg prednisolone or prednisone. Doses vary widely in different diseases and different patients. In more serious and life-threatening conditions, high doses of deflazacort may need to be given. When deflazacort is used long term in relatively benign chronic diseases, the maintenance dose should be kept as low as possible. Dosage may need to be increased during periods of stress or in exacerbation of illness. The dosage should be individually titrated according to diagnosis, severity of disease and patient response and tolerance. The lowest dose that will produce an acceptable response should be used (see Warnings and Precautions). Adults For acute disorders, up to 120 mg/day deflazacort may need to be given initially. Maintenance doses in most conditions are within the range 3 - 18 mg/day. The following regimens are for guidance only. Rheumatoid arthritis: The maintenance dose is usually within the range 3 - 18 mg/day. The smallest effective dose should be used and increased if necessary. Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms. Other conditions: The dose of deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5mg prednisone or prednisolone to 6mg deflazacort. https://www.medicines.org.uk/emc/print-document?documentId=20915 Página 1 de 8 Calcort 6mg Tablets - (eMC) print friendly 02/07/15 22:05 Hepatic Impairment In patients with hepatic impairment, blood levels of deflazacort may be increased. Therefore the dose of deflazacort should be carefully monitored and adjusted to the minimum effective dose. Renal Impairment In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. Elderly In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age (see Warnings and Precautions). Children There has been limited exposure of children to deflazacort in clinical trials. In children, the indications for glucocorticoids are the same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate (see Warnings and Precautions). Doses of deflazacort usually lie in the range 0.25 - 1.5 mg/kg/day. The following ranges provide general guidance: Juvenile chronic arthritis: The usual maintenance dose is between 0.25 - 1.0 mg/kg/day. Nephrotic syndrome: Initial dose of usually 1.5 mg/kg/day followed by down titration according to clinical need. Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25 - 1.0 mg/kg deflazacort on alternate days. Deflazacort withdrawal In patients who have received more than physiological doses of systemic corticosteroids (approximately 9mg per day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiological doses. Once a daily dose equivalent to 9mg deflazacort is reached, dose reduction should be slower to allow the HPA-axis to recover. Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 48 mg daily of deflazacort, or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less: • Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks. • When a short course has been prescribed within one year of cessation of long-term therapy (months or years). • Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy. • Patients receiving doses of systemic corticosteroid greater than 48 mg daily of deflazacort (or equivalent), • Patients repeatedly taking doses in the evening. 4.3 Contraindications Systemic infection unless specific anti-infective therapy is employed. Hypersensitivity to deflazacort or any of the ingredients. Patients receiving live virus immunisation. 4.4 Special warnings and precautions for use A patient information leaflet should be supplied with this product. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. https://www.medicines.org.uk/emc/print-document?documentId=20915 Página 2 de 8 Calcort 6mg Tablets - (eMC) print friendly 02/07/15 22:05 Undesirable effects may be minimised by using the lowest effective dose for the minimum period, and by administering the daily requirement as a single morning dose or whenever possible as a single morning dose on alternate days. Frequent patient review is required to appropriately titrate the dose against disease activity (see section 4.2). Adrenal suppression Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency which could be fatal, being tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy, any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy, they may need to be temporarily re-introduced. Patients should carry 'Steroid treatment' cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment. Anti-inflammatory/immunosuppressive effects and infection Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised. Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chicken pox should be advised to avoid close personal contact with chickenpox or herpes zoster and, if exposed, they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased. Patients should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed. Live vaccines should not be given to individuals with impaired responsiveness. The antibody response to other vaccines may be diminished. Systemic glucocorticoid treatment can cause chorioretinopathy which can lead to visual disorders including visual loss. Prolonged